TriangleNCT02719574 · OUTCOME
Phase 2, Cohort 3, 4, 5, 6, 7, 8: Percentage of Participants With CR Plus CRh for Acute Myeloid Leukemia Assessed by Investigator Based on IWG Response Criteria
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Phase 2: up to 3 weeks post last dose of study drug or until the introduction of new anticancer therapy, whichever is earlier (up to 82 months)
What was measured
Percentage of participants with CR plus CRh (CR, Molecular CR \[CRm\]), Cytogenetic CR \[CRc\], CRh) is re-ported. CR is defined as bone marrow blasts \<5 % (in aspirate with spicules and 200 nucleated cells), no blasts with auer rods, no extramedullary disease, ANC \>=1000/μL, platelet count \>=100,000/μL and transfusion independ-ence. CRc is defined as CR with no residual cytogenetic abnormalities. CRm is de-fined as CR with undetectable IDH1m MRD and CRh is defined as bone marrow blasts and partial recovery of peripheral blood counts (platelet count \>50 × 10\^9/L and ANC \> 0.5 × 10\^9/L).
Analysis population: FAS included all the participants who were enrolled in the study and have received at least one dose of FT-2102. This outcome measure is applicable for Cohort 3, 4, 5, 6, 7 and 8. Here, Overall Number of Participants Analyzed = participants with available data for this outcome measure.
Groups in this outcome
Phase 2: Cohort 3; FT-2102 (Single Agent)
Participants with R/R AML or MDS who were previously treated with FT-2102 and who underwent HSCT on-study then relapsed post-HSCT received single agent of FT-2102 150 mg BID in continuous 28-day cycles.
Phase 2: Cohort 4; FT-2102 + Azacitidine (Combination Therapy)
Participants with R/R AML that is naïve to prior hypomethylating therapy and IDH1 inhibitor therapy received combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
Phase 2: Cohort 5; FT-2102 + Azacitidine (Combination Therapy)
Participants with R/R AML/MDS that have inadequately responded to or have progressed on prior hypo-methylating therapy received combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
Phase 2: Cohort 6; FT-2102 + Azacitidine (Combination Therapy)
Participants with R/R AML/MDS that have been previously treated with single agent FT-2102 as their last therapy prior to study enrolment received combination therapy of azacitidine + FT-2102 150 mg BID in continuous 28-day cycles. Participants from the FT-2102 single agent cohorts of this study allowed to be enrolled in Cohort 6 after their disease progression.
Phase 2: Cohort 7; FT-2102 (Single Agent)
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given single agent of FT-2102 150 mg BID in continuous 28-day cycles.
Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy)
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
| Group | Source count |
|---|---|
| Phase 2: Cohort 3; FT-2102 (Single Agent) | 5 |
| Phase 2: Cohort 4; FT-2102 + Azacitidine (Combination Therapy) | 19 |
| Phase 2: Cohort 5; FT-2102 + Azacitidine (Combination Therapy) | 13 |
| Phase 2: Cohort 6; FT-2102 + Azacitidine (Combination Therapy) | 20 |
| Phase 2: Cohort 7; FT-2102 (Single Agent) | 10 |
| Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy) | 11 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2: Cohort 3; FT-2102 (Single Agent) | 0 | Not reported | 0.0 | 52.2 | Not reported |
| Phase 2: Cohort 4; FT-2102 + Azacitidine (Combination Therapy) | 47 | Not reported | 24.4 | 71.1 | Not reported |
| Phase 2: Cohort 5; FT-2102 + Azacitidine (Combination Therapy) | 38 | Not reported | 13.9 | 68.4 | Not reported |
| Phase 2: Cohort 6; FT-2102 + Azacitidine (Combination Therapy) | 30 | Not reported | 11.9 | 54.3 | Not reported |
| Phase 2: Cohort 7; FT-2102 (Single Agent) | 40 | Not reported | 12.2 | 73.8 | Not reported |
| Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy) | 45 | Not reported | 16.7 | 76.6 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.0
- upper Limit
- 52.2
- value
- 0
- group Id
- OG001
- lower Limit
- 24.4
- upper Limit
- 71.1
- value
- 47
- group Id
- OG002
- lower Limit
- 13.9
- upper Limit
- 68.4
- value
- 38
- group Id
- OG003
- lower Limit
- 11.9
- upper Limit
- 54.3
- value
- 30
- group Id
- OG004
- lower Limit
- 12.2
- upper Limit
- 73.8
- value
- 40
- group Id
- OG005
- lower Limit
- 16.7
- upper Limit
- 76.6
- value
- 45
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 19
- group Id
- OG002
- value
- 13
- group Id
- OG003
- value
- 20
- group Id
- OG004
- value
- 10
- group Id
- OG005
- value
- 11
- units
- Participants
- description
- Percentage of participants with CR plus CRh (CR, Molecular CR \[CRm\]), Cytogenetic CR \[CRc\], CRh) is re-ported. CR is defined as bone marrow blasts \<5 % (in aspirate with spicules and 200 nucleated cells), no blasts with auer rods, no extramedullary disease, ANC \>=1000/μL, platelet count \>=100,000/μL and transfusion independ-ence. CRc is defined as CR with no residual cytogenetic abnormalities. CRm is de-fined as CR with undetectable IDH1m MRD and CRh is defined as bone marrow blasts and partial recovery of peripheral blood counts (platelet count \>50 × 10\^9/L and ANC \> 0.5 × 10\^9/L).
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with R/R AML or MDS who were previously treated with FT-2102 and who underwent HSCT on-study then relapsed post-HSCT received single agent of FT-2102 150 mg BID in continuous 28-day cycles.
- id
- OG000
- title
- Phase 2: Cohort 3; FT-2102 (Single Agent)
- description
- Participants with R/R AML that is naïve to prior hypomethylating therapy and IDH1 inhibitor therapy received combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
- id
- OG001
- title
- Phase 2: Cohort 4; FT-2102 + Azacitidine (Combination Therapy)
- description
- Participants with R/R AML/MDS that have inadequately responded to or have progressed on prior hypo-methylating therapy received combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
- id
- OG002
- title
- Phase 2: Cohort 5; FT-2102 + Azacitidine (Combination Therapy)
- description
- Participants with R/R AML/MDS that have been previously treated with single agent FT-2102 as their last therapy prior to study enrolment received combination therapy of azacitidine + FT-2102 150 mg BID in continuous 28-day cycles. Participants from the FT-2102 single agent cohorts of this study allowed to be enrolled in Cohort 6 after their disease progression.
- id
- OG003
- title
- Phase 2: Cohort 6; FT-2102 + Azacitidine (Combination Therapy)
- description
- Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given single agent of FT-2102 150 mg BID in continuous 28-day cycles.
- id
- OG004
- title
- Phase 2: Cohort 7; FT-2102 (Single Agent)
- description
- Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
- id
- OG005
- title
- Phase 2: Cohort 8; FT-2102 + Azacitidine (Combination Therapy)
- param Type
- NUMBER
- population Description
- FAS included all the participants who were enrolled in the study and have received at least one dose of FT-2102. This outcome measure is applicable for Cohort 3, 4, 5, 6, 7 and 8. Here, Overall Number of Participants Analyzed = participants with available data for this outcome measure.
- reporting Status
- POSTED
- time Frame
- Phase 2: up to 3 weeks post last dose of study drug or until the introduction of new anticancer therapy, whichever is earlier (up to 82 months)
- title
- Phase 2, Cohort 3, 4, 5, 6, 7, 8: Percentage of Participants With CR Plus CRh for Acute Myeloid Leukemia Assessed by Investigator Based on IWG Response Criteria
- type
- PRIMARY
- unit Of Measure
- Percentage of participants
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Preserved source evidence · Not medical advice